—#179173

Product

10 cc Luer-Slip Loss of Resistance Syringe, Product Code LR-05501

FDA product code: FMF — Syringe, Piston
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Lots: 13F18J0916 13F19C0321 13F19G0070 13F19H0274 13F19J0039 13F19L0252 13F18K0675 13F19D0335 13F19G0071 13F19H0275 13F19J0040 13F18L0737 13F19E0141 13F19G0458 13F19H0634 13F19J0596 13F18M0178 13F19E0212 13F19H0085 13F19J0038 13F19K0097

Why it was recalled

There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.

Root cause (FDA determination)

Other

Action the firm took

An Urgent Medical Device Recall notification letter dated 1/15/20 was sent to customers. Our records indicate you have received products that are subject to this field action. We are now notifying our customers to take the following actions: 1. If you have affected stock, immediately identify product, discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. To acknowledge receipt of this Urgent Medical Device Recall Notice or to return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document your receipt of this letter.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern: The products were distributed to the following US states: AK, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY.

Timeline

Recall initiated: 2020-01-15
Posted by FDA: 2020-01-24
Terminated: 2023-03-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179173. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.